FloTrac IQ, VAMP Optima MHDQ8VRL5

GUDID 50690103199166

FloTrac IQ sensor with VAMP Optima system

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use Invasive-pressure external transducer, single-use

• Primary Device ID: 50690103199166
• NIH Device Record Key: 1f618fb5-f232-4eca-ae9f-1c1ebd943e2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FloTrac IQ, VAMP Optima
• Version Model Number: MHDQ8VRL5
• Catalog Number: MHDQ8VRL5
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Length: 84 Inch
• Length: 84 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103199161 [Primary]
GS1	50690103199166 [Package]; Contains: 00690103199161; Package: Shipper [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180275

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-21
• Device Publish Date: 2018-11-20

On-Brand Devices [FloTrac IQ, VAMP Optima]

• 50690103199166: FloTrac IQ sensor with VAMP Optima system
• 00690103199154: FloTrac IQ sensor with VAMP Optima system
• 50690103199098: FloTrac IQ sensor with VAMP Optima system
• 00690103199086: FloTrac IQ Sensor with VAMP Optima system